Job Overview
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions
• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files and completeness.
• Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Act as a mentor for less experienced Clinical Trial Assistants (CTAs).
• Assist with training and onboarding of new CTAs.
• May serve as subject matter expert for business processes.
• May lead CTA study teams.
• May assist with interviewing and screening of potential new team members
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
• May participate in departmental quality or process improvement initiatives.

Qualifications
• Preferred background in life-science or health-care related qualification or equivalent work experience
• Previous administrative experience is desired. Clinical related experience in a medical profession, pharmaceutical, or diagnostic company is preferred
• Ability to manage multiple projects and prioritize appropriately.  Ability to develop, lead and conduct training activities for new and current staff. Serve as mentor as needed .

• Proficient in application of the conduct of clinical trials and its associated activities and responsibilities
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
• Effective written and verbal communication skills including good command of English language.
• Demonstrate consistent critical thinking and problem solving methodologies
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Preferred with a proven track record of success and a basic knowledge related to ICH/GCP Guidelines and applicable local regulations.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com